Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

This guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Keywords: availability, limited market, Article 4, Article 8, Article 23, eligibility, Regulation (EU) 2019/6, efficacy, target animal safety, data requirements

Current version

Draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6

Consultation dates: 21/07/2023 to 31/01/2024Draft: consultation openReference Number: EMA/CVMP/EWP/231668/2022Summary:

This guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Comments should be provided using this template.

Document history

Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6

Consultation dates: 15/10/2021 to 15/12/2021Draft: consultation closedReference Number: EMA/CVMP/435071/2021

Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1

AdoptedReference Number: EMA/CVMP/EWP/117899/2004–Rev.1

Overview of comments received on 'Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'

Reference Number: EMA/CVMP/EWP/523421/2016

Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1

Consultation dates: 03/02/2016 to 31/07/2016Draft: consultation closedReference Number: EMA/CVMP/EWP/117899/2004 Rev.1Summary:

In order to stimulate the development of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals and a guideline for immunologicals.

Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species

AdoptedLegal effective date: 20/07/2006Reference Number: EMEA/CVMP/EWP/117899/2004

Overview of comments received on draft guideline efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species

Reference Number: EMEA/CVMP/EWP/43872/2006

Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species

Draft: consultation closedReference Number: EMEA/CVMP/EWP/117899/2004

Points to consider regarding efficacy requirements for minor species and minor indications

Reference Number: EMEA/CVMP/610/01-Consultation